To Investigate Safety, Tolerability, and Pharmacokinetics of Treatment With BI 660848 Rising Single Doses (From 2 mg to 600 mg) Administered as Oral Drinking Solution (Powder in Bottle). - Full Text View

Purpose

As a transition from preclinical investigations to clinical development in this first-in-human trial, safety, tolerability, and pharmacokinetics of BI 660848 will be assessed in human male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of BI 660848 in the indication of neuropathic pain.

Condition	Intervention	Phase
Pain Healthy	Drug: BI 660848 Drug: BI 660848 Drug: BI 660848 Drug: BI 660848 Drug: BI 660848 Drug: BI 660848 Drug: BI 660848 Drug: BI 660848 Drug: BI 660848 Drug: BI 660848 Drug: BI 660848 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Phase I - Study to a) Assess Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses 2 mg to 600 mg of BI 660848 Administered as Oral Drinking Solution (Powder in Bottle) in Healthy Male Volunteers, b) to Explore the Relative Oral Bioavailability of an Immediate Release Tablet Formulation and c) to Assess the Impact of a High Fat Meal on the Oral Bioavailability of the Oral Drinking Solution (Powder in Bottle).

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Safety and tolerability (number and intensity of adverse events). [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Changes in blood pressure. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Changes in pulse rate. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Changes in respiratory rate. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Changes in 12-lead ECG. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Changes in clinical laboratory test parameters. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
tmax (time from dosing to maximum measured concentration) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
AUC (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
MRT (mean residence time of the analyte in the body after drug intake) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
CL/F (apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
CL R,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment:	72
Study Start Date:	May 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BI 660848 2 mg oral drinking solution	Drug: BI 660848 2 mg oral drinking solution
Experimental: BI 660848 10 mg oral drinking solution	Drug: BI 660848 10 mg oral drinking solution
Experimental: BI 660848 20 mg oral drinking solution	Drug: BI 660848 20 mg oral drinking solution
Experimental: BI 660848 50 mg oral drinking solution	Drug: BI 660848 50 mg oral drinking solution
Experimental: BI 660848 100 mg oral drinking solution	Drug: BI 660848 100 mg oral drinking solution
Experimental: BI 660848 150 mg oral drinking solution	Drug: BI 660848 150 mg oral drinking solution
Experimental: BI 660848 200 mg oral drinking solution	Drug: BI 660848 200 mg oral drinking solution
Experimental: BI 660848 400 mg oral drinking solution	Drug: BI 660848 400 mg oral drinking solution
Experimental: BI 660848 600 mg oral drinking solution	Drug: BI 660848 600 mg oral drinking solution
Experimental: BI 660848 10,0 mg immediate release tablet	Drug: BI 660848 10,0 mg immediate release tablet
Experimental: BI 660848 50,0 mg immediate release tablet	Drug: BI 660848 50,0 mg immediate release tablet
Experimental: Placebo matching placebo (oral drinking solution and IR tablets)	Drug: Placebo matching placebo (oral drinking solution and IR tablets)

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria

Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12 lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
Age 21 and 50 years
BMI 18.5 and <30 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion criteria

Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
Evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
Intake of drugs with a long half-life (24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation
Participation in another trial with an investigational drug within 2 months prior to randomisation
Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
Inability to refrain from smoking on trial days as judged by the investigator
Alcohol abuse (more than 30 g alcohol a day)
Drug abuse
Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
Excessive physical activities within 1 week prior to randomisation or during the trial
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of the study centre

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145014

Locations

Germany
1284.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01145014 History of Changes
Other Study ID Numbers:	1284.1, 2009-015995-90
Study First Received:	May 5, 2010
Last Updated:	May 18, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on May 19, 2013